A third member of a Food and Drug Administration expert panel has resigned over the approval of a controversial new Alzheimer's drug.
Biogen's new Alzheimer's drug, Aduhelm, "was probably the worst drug approval decision in recent US history."of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee, who resigned from their positions earlier this week, as the backlash against the agency's accelerated approval process continues to mount.
The drug has been a point of debate in the scientific community for years, because it failed one of its late-stage clinical trials, and another trial failed to produce conclusive evidence that Aduhelm helped patients with memory and cognition issues. "This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system," Kesselheim wrote."Similar to personnel matters, the FDA doesn't comment on matters related to individual members of advisory committees," a representative told Insider.
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